PMA
P210030: Roadsaver/CASPER Carotid Stent Device
FDA PMA · Stent, carotid · MicroVention, Inc.
Key facts
| PMA number | P210030 |
|---|---|
| Trade name | Roadsaver/CASPER Carotid Stent Device |
| Generic name | Stent, carotid |
| Applicant | MicroVention, Inc. |
| Owner/operator | MicroVention Inc. |
| Product code | NIM |
| Approval date | Nov 20, 2024 |
| Establishment registration | 3013556777 |
| FEI number | 3013556777 |
At a glance
- 1–9 Supplements
- Jul 7, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: